The U.S. Department of Health and Human Services announced that six states have received a supply of remdesivir, and seven more states will receive a supply this week. HHS expects a supply to be delivered to each state from the 607,000 vials of remdesivir donated to the Federal Stockpile by Gilead. State health departments will decide on distribution within their state. HHS advised healthcare providers caring for patients with severe COVID-19 on ventilators or ECMO, who wish to use remdesivir, to contact their state health department to request a supply of the drug.
Researchers performed an observational study of 1,376 consecutive COVID-19 patients. An adjusted analysis of data found no evidence to support a reduction in death or intubation with hydroxychloroquine.
Interferon Triple Combination
In a 127 patient, open-label, Phase II trial, treatment with lopinavir/ritonavir, ribavirin and interferon beta-1b reduced the time to a negative nasopharyngeal swab for COVID-19 compared to lopinavir/ritonavir and ribavirin from 12 days to seven days in hospitalized adults with COVID-19 in Hong Kong. Alleviation of symptoms (NEWS2 score of 0) was also reduced from eight days in the control group to four days in the interferon group.
Cytodyn announced that 10 patients with critical COVID-19 infections had a better immune response than healthy controls. Novant Health is evaluating Cytodyn’s investigational CCR5 antagonist, leronlimab, as a treatment for COVID-19 in a 28-day, 390 patient, Phase III trial.
BioNTech and Pfizer initiated a 200 patient, Phase I/II trial in Germany in April and a second 360 patient Phase I/II trial in the U.S. in May. Four vaccine candidates are being tested. Three require two doses, while the fourth contains self-amplifying mRNA and requires a single dose. Pfizer expects initial data from the trials in May or June with a successful vaccine candidate moving to larger trials and possibly emergency use or accelerated approval in the 4Q20.
Sanofi and GlaxoSmithKline have agreed to work together to develop a vaccine for COVID-19. The companies will use Sanofi’s S-protein COVID-19 antigen based on the company’s recombinant DNA tech in combination with GSK’s pandemic adjuvant technology. The recombinant DNA platform is the same one used to create the quadrivalent influenza vaccine FluBlok. GSK’s vaccine adjuvant reduces the amount of antigen required for a dose enabling a quicker way to scale up production. Both companies have the capacity to manufacture vaccines on a global scale and project the capacity to manufacture over a billion doses. The companies plan to initiate a large Phase I/II trial with several hundred patients in September 2020. A Phase III trial is planned for late 2020 or early 2021. The companies hope to file a BLA in the second half of 2021.